Accidental ingestion of benzonatate (Tessalon) by children younger than 10 years can result in serious adverse effects or death, the US Food and Drug Administration (FDA) announced today.

Benzonatate, a round, liquid-filled gelatin capsule, is approved for symptomatic relief of cough in children older than 10 years but may represent a danger to younger children because of its candy-like appearance.

"The FDA encourages healthcare professionals to talk with their patients and those caring for children about the risk of accidental ingestion or overdose," Carol Holquist, RPh, director of the FDA's Division of Medication Error Prevention and Analysis, said in a news release. "Benzonatate should be kept in a child-resistant container and stored out of reach of children," she added.